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IRCT20230224057517N1 IRCT 2023-04-18 Arak University of Medical Sciences The effect of a diet with simple carbohydrates on the treatment of infantile colic The effect of a diet with low FODMAP (oligosaccharides, disaccharides, monosaccharides and fermentable polyols) in the diet of breastfeeding mothers on the treatment of infantile colic 2023-05-22 anticipated 110 Complete https://irct.ir/trial/69448 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The participants in this study are divided into two groups, one (intervention) and two (control) , and the first group receives only one type of intervention during the study. Both groups are subjected to the same conditions during the study and only the first group receives the intervention we are considering, Randomization description: To assign people to two groups, a block randomization method with a block size of 4 will be used, and by using this method, concealment will be observed. In this method, each person is assigned a unique code, Blinding description: Blinding in this study is one-way blind. In fact , the participants included in this study, despite knowing all the advantages and disadvantages of this study, as well as having full consent and knowledge of participating in this study, have been placed as our blinding groups and are not aware of the type of treatment and study. N/A Infantile colic. Intervention 1: Intervention group: The intended intervention will include giving the special diet for breastfeeding with low FODMAP for two weeks to the target group and then checking and comparing it with the control group. The diet considered for mothers will be three main meals, one snack in the morning and one snack in the afternoon. The selection of the ingredients of the food consumed by the mother will be done according to the guidance of the FODMAP database of Monash University, and according to that, a diet plan will be prepared by the nutritionist and will be provided to the participants. It is necessary to mention that the diet recommended to each of the participants is completely diverse, selective and based on the common and widely used foods of families, and only their consumption amount will be variable; In other words, the participants are given the right to choose the type of meal according to their preferences during the day, and families are not required to pay additional fees to comply with their diet. Intervention 2: Control group: It will include giving a special diet for breastfeeding for two weeks. The diet considered for mothers will be three main meals, one snack in the morning and one snack in the afternoon. The selection of the ingredients of the food consumed by the mother will be done according to the guidance of the FODMAP database of Monash University, and according to that, a diet plan will be prepared by the nutritionist and will be provided to the participants. It is necessary to mention that the diet recommended to each of the participants is completely diverse, selective and based on the common and widely used foods of families, and only their consumption amount will be variable; In other words, the participants are given the right to choose the type of meal according to their preferences during the day, and families are not required to pay additional fees to comply with their diet. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Reyhaneh Aghaziaraty
Arak University of Medical Sciences, Basij sq.
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 www.reyhanehziaraty550@gmail.com Arak University of Medical Sciences scientific Reyhaneh Aghaziaraty
Arak University of Medical Sciences, Basij sq.
Arak Iran (Islamic Republic of) 3819693345 0098863313147 www.reyhanehziaraty550@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Term baby (38 to 42 weeks) Mother with at least middle school education Exclusive breastfeeding Age less than 5 months at the time of study Crying more than 3 hours a day for 3 to more than 3 days a week Not suffering from underlying diseases (gastrointestinal tract, kidney, lung, etc.) and not suffering from congenital abnormalities Average family income level no limit 5 months Both Non-completion or incomplete completion of the case registration sheet by the mother Failure to follow the correct diet by the mother R10.4 Other and unspecified abdominal pain Other Other Intervention group: The intended intervention will include giving the special diet for breastfeeding with low FODMAP for two weeks to the target group and then checking and comparing it with the control group. The diet considered for mothers will be three main meals, one snack in the morning and one snack in the afternoon. The selection of the ingredients of the food consumed by the mother will be done according to the guidance of the FODMAP database of Monash University, and according to that, a diet plan will be prepared by the nutritionist and will be provided to the participants. It is necessary to mention that the diet recommended to each of the participants is completely diverse, selective and based on the common and widely used foods of families, and only their consumption amount will be variable; In other words, the participants are given the right to choose the type of meal according to their preferences during the day, and families are not required to pay additional fees to comply with their diet. Control group: It will include giving a special diet for breastfeeding for two weeks. The diet considered for mothers will be three main meals, one snack in the morning and one snack in the afternoon. The selection of the ingredients of the food consumed by the mother will be done according to the guidance of the FODMAP database of Monash University, and according to that, a diet plan will be prepared by the nutritionist and will be provided to the participants. It is necessary to mention that the diet recommended to each of the participants is completely diverse, selective and based on the common and widely used foods of families, and only their consumption amount will be variable; In other words, the participants are given the right to choose the type of meal according to their preferences during the day, and families are not required to pay additional fees to comply with their diet. Colic recovery status of infants in the Barr scale. Timepoint: The beginning of the study, the seventh day and the fourteenth day after the intervention. Method of measurement: Children's daily behavior measurement scale ( Barr scale ). The number of feedings of infants in 24 hours. Timepoint: The beginning of the study, the seventh day and the fourteenth day after the intervention. Method of measurement: Children's daily behavior measurement scale ( Barr scale ). Average 24 hour sleep of infants. Timepoint: The beginning of the study, the seventh day and the fourteenth day after the intervention. Method of measurement: Children's daily behavior measurement scale ( Barr scale ). Average 24 hours length of crying and fussing. Timepoint: The beginning of the study, the seventh day and the fourteenth day after the intervention. Method of measurement: Children's daily behavior measurement scale ( Barr scale ). The average feeding time of infants during 24 hours. Timepoint: The beginning of the study, the seventh day and the fourteenth day after the intervention. Method of measurement: Children's daily behavior measurement scale ( Barr scale ). The number of times infants crying in 24 hours. Timepoint: The beginning of the study, the seventh day and the fourteenth day after the intervention. Method of measurement: Children's daily behavior measurement scale ( Barr scale ). The number of times infants have flatulence in 24 hours. Timepoint: The beginning of the study, the seventh day and the fourteenth day after the intervention. Method of measurement: Children's daily behavior measurement scale ( Barr scale ). Arak University of Medical Sciences Approved 2022-11-20 Ethics committee of Arak University of Medical Sciences Arak University of Medical SciencesŲŒ Basij sq. Arak Markazi Iran (Islamic Republic of)